Drug News 15 to 21 April 2024
European Medicine Agency (EMA) The EMA’s Committee for Medicinal Products for Human Use (CHMP) is scheduled to hold its monthly meeting from April 22 to 25. US Food and Drug Administration (FDA) The FDA made the following decisions: New data from clinical trials (Phase 2, Phase 3) Here are the recent updates on Phase 2 […]
HE Advisory drug news: 25 to 31 March 2024
European Medicine Agency (EMA) Following a positive opinion from the CHMP, the European Commission (EC) has approved Otsuka and Lundbeck’s Abilify Maintena (aripiprazole) as a once-every-two-months long-acting injectable formulation for the maintenance treatment of schizophrenia. Lundbeck press release. The European Medicines Agency (EMA) has granted priority medicines (PRIME) status to 89bio’s pegozafermin for the treatment of […]
FDA and EMA activity last week (08 to 14 January 2024): drug approvals, positive opinions, safety surveillance and alerts
European Medicine Agency (EMA) The next CHPM meeting is planned on the of week of 22 Jan 2024.If you are interested about the summary of previous CHMP meetings, send an email to [email protected] with in the title: CHMP, we will take care of it. US Food and Drug Administration (FDA) No new drugs were approved […]
FDA and EMA activity this week (02 to 08 Dec 2023): drug approvals, positive opinions, safety surveillance and alerts
European Medicine Agency (EMA) This week, the European Medicines Agency (EMA) and the European Commission have approved new drugs for specific indications: ELREXFIO® (elranatamab) by Pfizer: This drug has been approved for the treatment of relapsed and refractory multiple myeloma. ELREXFIO is a bispecific antibody immunotherapy delivered subcutaneously. It targets BCMA on myeloma cells and CD3 […]
InspectIR snags FDA approval, 1st breathing covid test
Earlier this week, the US-FDA announced the issue of an Emergency use authorisation (EUA) for new technology: a breathing covid detector named InspectIR developed by IR Systems LLC. The diagnostic system, looking for specific molecules in the breath, can detect the signature of Covid-19 ongoing infection. The detection of those molecules is performed by gas […]